The Safety of Proctofoam-HC in the Third Trimester of Pregnancy
The purpose of this study is to evaluate the fetal safety of topical application of Proctofoam-HC®, an antihemorrhoidal, in the third trimester of pregnancy.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||The Safety of Proctofoam-HC in the Third Trimester of Pregnancy|
- Birth-weight [ Time Frame: until delivery ] [ Designated as safety issue: Yes ]Weight of the baby measured in grams at time of birth.
- Gestational Age at Delivery [ Time Frame: until delivery ] [ Designated as safety issue: Yes ]Fetal gestational age at delivery
- Mode of Delivery [ Time Frame: at birth ] [ Designated as safety issue: No ]Method of delivery for both groups: vaginal or caesarean section
- Prematurity [ Time Frame: at birth ] [ Designated as safety issue: Yes ]birth at <37 gestational weeks
- Fetal Distress [ Time Frame: at birth ] [ Designated as safety issue: Yes ]Presence of fetal distress at birth: heart deceleration/acceleration, meconium/amniotic fluid
- Low Birth Weight at Birth [ Time Frame: at birth ] [ Designated as safety issue: Yes ]Low birth weight (birth weights <2500 grams)
- Neonatal Health [ Time Frame: at birth ] [ Designated as safety issue: Yes ]Neonatal health at birthyes=need for medical attention or intervention after birth, abnormalities detected, no= no need for medical attention, no abnormalities detected at birth
|Study Start Date:||November 2006|
|Study Completion Date:||June 2010|
|Primary Completion Date:||November 2009 (Final data collection date for primary outcome measure)|
Women in the third trimester of pregnancy prescribed Proctofoam-HC® aerosol foam canister for 36 applications for treatment of symptoms of hemorrhoids. One applicatorful is to be applied into the anus (or on the perianal area) two or three times daily and after bowel evacuation.
Observational study of the exposure to Proctofoam-HC®
Other Name: 1% Pramoxine+1% Hydrocortisone ( Proctofoam-HC®)
Control group of women in the third trimester of pregnancy who were not exposed to any teratogens during the course of the pregnancy, and to Proctofoam-HC any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.
Hemorrhoids are a frequent condition in pregnancy. The rate is increased as pregnancy progresses, and they affect up to 24% of pregnant women in the third trimester. Complications of untreated hemorrhoids include bleeding, prolapse, soiling, discharge with perianal irritation and itching, and in severe cases, severe pain and venous engorgement which could even lead to thrombosis and infarction. Hemorrhoids are treated with a variety of suppositories and gels, based on analgesic and anti-inflammatory effects. The safety of these antihemorrhoidal products has not yet been documented in pregnant women.
Proctofoam-HC® has been on the Canadian market for 25 years. It combines the anti-inflammatory action of hydrocortisone with the surface anesthetic effect of pramoxine HCl. It is approved for temporary relief of anorectal inflammation, pruritus, pain and swelling associated with haemorrhoids, fissures, pruritus ani, cryptitis, proctitis and postoperative pain.
We hypothesize that local application of Proctofoam-HC® in the third trimester of pregnancy is safe for the mother and fetus.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00405288
|Mount Sinai Hospital|
|Toronto, Ontario, Canada, M5G 1X5|
|The Hospital for Sick Children|
|Toronto, Ontario, Canada, M5G 1X8|
|Principal Investigator:||Gideon Koren, MD||The Hospital for Sick Children, Toronto Canada|